Dural biological patch and preparation method thereof

A biological patch, dura mater technology, applied in tissue regeneration, medical science, prosthesis, etc., can solve the problems of weak mechanical strength, insufficient mechanical properties of dura mater, unable to effectively meet the actual clinical needs, etc., and achieve the mode of action. Strong, unique mode of action, complete decellularization effect

Active Publication Date: 2019-10-15
上海白衣缘生物工程有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The purpose of the present invention is to aim at the weak mechanical strength of the existing dura mater biological patch, which cannot effectively meet the actual clinical needs; Focusing on the specific technical feature of patch biomechanics, through a large number of literature readings, combined with my own careful analysis of academic theories, and years of rich work experience, the theory and practice are closely combined, which is unexpected but reasonable, ingenious and convenient Solved the technical problem of insufficient mechanical properties of common dura mater patches

Method used

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  • Dural biological patch and preparation method thereof
  • Dural biological patch and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0090] Example 1 (multiparous sows 24 months + 0.25% Saponin)

[0091] The preparation of porcine small intestinal submucosa dura patch, the specific steps are as follows:

[0092] 1) Take materials and wash them: pretreatment: According to the breeding records, select the double multiparous sows that have been bred for about 24 months and are in the open conception stage, and clean the fresh small intestine tissues after slaughtering;

[0093]2) Pretreatment: Use physical scraping to remove the mucous layer, muscular layer, serosa layer, and lymph nodes of the small intestine of the pig, separate the submucosa, and soak in 0.5% acetic acid solution for 30 minutes. The ratio of the pig small intestine to the acetic acid solution is 1: 5. Soak in purified water for 3 times to obtain the raw material of the biological patch, that is, the submucosa of the small intestine, hereinafter referred to as SIS material;

[0094] 3) Disinfection: use a mixed aqueous solution containing 1...

Embodiment 2

[0100] Example 2 (culled sows + 0.25% Saponin)

[0101] The pretreatment of the small intestine tissue, disinfection, degreasing, decellularization, DNA and α-Gal antigen removal, freeze-drying, sterilization and other steps are completely the same as in Example 1; the difference is only in the initial selection of animals. In the farm, the fresh small intestines of eliminated sows were selected as raw materials for patches; after in-depth understanding, the eliminated binary mixed sows usually had more than 8 parities and weighed about 180 kg, and they were all empty pregnant; Sows have been raised for more than 40 months.

Embodiment 3

[0102] Embodiment 3 (commercial pigs for sale + 0.25% Saponin)

[0103] The pretreatment of small intestine tissue, disinfection, degreasing, decellularization, DNA and α-Gal antigen removal, freeze-drying, sterilization and other steps are completely the same as in Example 1; the difference is only in the initial selection of animals; In the field, the fresh small intestine tissue of the Du Chang Sanyuan miscellaneous commodity pork pig with a weight of about 100 kg was cleaned; it was learned that the number of days of feeding was 160-180 days.

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Abstract

The invention belongs to the field of biological patches, and relates to a dural biological patch and a preparation method thereof. The raw material of the dural biological patch of the invention is not from commercial meat animals, but from breeding animals, such as a multiparous sow SIS patch, which has natural and good mechanical properties; plant-derived reagents are adopted in the decellularization link in the method of the invention, using such natural mild reagents has no damage to ECM natural structural base, can retain more effective active ingredients, and has better ability of inducing tissue repair and growth; and the method of the invention neither uses a crosslinking agent to enhance the mechanical properties, nor uses a synthetic detergent for decellularization, so as to avoid the residue of chemical reagents and the toxicity of the residue, and retain more active components in the ECM at the same time, especially the content of GAGs. According to the present invention,the dural biological patch not only has soft texture and good toughness, is easy to suture tightly, and can prevent cerebrospinal fluid leakage, but also has the characteristics that the degradation speed is basically synchronous with the growth of new dura, and is more conducive to the repair and regeneration of the dura.

Description

technical field [0001] The invention relates to the field of biological materials for tissue repair, in particular to a dura mater biological patch and a preparation method thereof. Background technique [0002] The dura mater, also known as the dura mater, is an important barrier to protect the brain tissue, and is of great significance for maintaining the structure and functional activities of the nervous system; the dura mater is a thick and tough double-layer membrane. The outer layer is the periosteum on the inner surface of the skull, which is only loosely attached to the calvaria, especially in the occipital and temporal parts, and is called the periosteum layer. However, the sutures of the skull and the base of the skull are more firmly attached and difficult to separate. There is no intracranial intradural space. The inner layer of the dura mater is thicker and tougher than the outer layer, and it is continuous with the dura mater at the foramen magnum, called the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F2/02
CPCA61F2/02A61F2240/001A61L27/3604A61L27/362A61L27/3629A61L27/3645A61L27/3687A61L2430/40
Inventor 韩韦红葛翠兰钱锵张国强
Owner 上海白衣缘生物工程有限公司
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